Toxic Baby Formula NEC Lawsuit

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Jessie Paluch

Attorney Jessie Paluch, founder of TruLaw, has over 25 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLawsuit Info and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.

TruLawsuit Info does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact our team by using the chat on the bottom of this page. This article should not be taken as advice from an attorney.

Toxic Baby Formula NEC Lawsuit

Toxic Baby Formula lawsuits have been on the increase, with more and more parents coming forward to report serious health problems in their children after using certain baby formulas.

The main target of these lawsuits has been Abbott Laboratories, the manufacturer of a baby formula called Similac, and Mead Johnson, the manufacturer of Enfamil formula.

toxic baby formula nec lawsuit

NEC, or Necrotizing Enterocolitis, is a serious and potentially fatal condition that can occur in infants.

These NEC formula lawsuits allege that the companies didn’t alert parents to the dangers of their products.

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Lawsuit Updates

  • October 27, 2025: Abbott Prevails in Third NEC Formula Bellwether Trial

    Abbott Laboratories secured its third bellwether victory in the multidistrict litigation alleging that its Similac Special Care formula causes necrotizing enterocolitis (NEC) in premature infants.

    U.S. District Judge Rebecca Pallmeyer ruled that plaintiffs failed to demonstrate that a human-milk-based alternative, such as Prolacta, was a feasible large-scale substitute.

    The court sided with Abbott’s experts, who testified that large-scale human milk production is limited by donor availability, ethical concerns, and high costs.

    Although Judge Pallmeyer acknowledged that breast milk poses fewer risks, she concluded that Abbott’s formula remains essential for infants without access to human milk.

    The ruling strengthens Abbott’s position in the ongoing Preterm Infant Nutrition MDL, where the company continues to assert that its products are safe, scientifically validated, and necessary for neonatal care.

What is the NEC lawsuit?

The Toxic Baby Formula NEC lawsuit is a class action lawsuit brought primarily against the manufacturers of Similac and Enfamil baby formula.

The suit alleges that the companies knew or should have known that their products were potentially harmful to premature babies and infants and failed to warn consumers of the risks.

The infant formula lawsuits seek damages for medical expenses, pain and suffering, and other losses suffered by the parents of affected infants.

If you are the parent or guardian of a child who was born prematurely and/or suffered from NEC, you may be eligible to file a claim in this lawsuit.

If you have any questions about the legal procedure, open our chatbot below for a case evaluation.

How did these baby formula lawsuits come about?

Civil lawsuits involving premature babies suffering from NEC began to be filed in state and federal courts as early as 2015, where one mother filed a case reporting that her baby developed NEC and brain damage after being fed Enfamil.

The Toxic Baby Formula lawsuit became a class action lawsuit, with thousands of parents claiming against baby formula manufacturers.

Premature babies are often fed cow milk formulas instead of human breast milk, and some of these formulas have caused many premature infants to develop NEC due to their underdeveloped digestive systems.

What formulas are involved in the NEC lawsuit?

The main formula brands involved in the Toxic Baby Formula lawsuit are Enfamil and Similac, along with some other lesser-known brands.

These companies create formulas for infants and babies who cannot take breast milk for varying reasons, and these products are often given to infants in hospitals.

The baby formula lawsuit claims that these companies knew that their products could cause NEC in premature babies due to their cow milk-based formula, yet they never issued any kind of warnings to parents or hospitals.

Which baby formula manufacturers are at fault?

The Toxic Baby Formula lawsuits involve a few different brands of formula milk, but the main manufacturers at fault are Mead Johnson’s Enfamil and Abbott Laboratories’ Similac.

As mentioned previously, the Enfamil and Similac cow-milk-based formulas have been linked to NEC, yet the products were never labelled with warnings.

These companies make formulas that are often given to premature babies in hospitals who can’t suckle on breast milk – making the impact all the more devasting for parents who believed their children were receiving high-quality medical attention.

Who is Enfamil?

Enfamil is a cow-milk-based formula that can be taken instead of breast milk, and it is made by Mead Johnson.

Mead Johnson is a subsidiary of Reckitt Benckiser, which is a British company.

Enfamil is one of the most popular formulas on the market, and its infant formula milk is given to premature babies around the world, but especially in the U.S.

Enfamil has faced various lawsuits in 2022 – not only is it undergoing severe scrutiny and facing NEC lawsuits, but the company has also been sued for false advertising.

The claims were that Enfamil’s advertising misled parents into thinking that the formula could make more milk for their babies than was actually the case.

Unlike the Toxic Baby Formula lawsuits, the class action lawsuit against Mead Johnson has now been settled, with a maximum of $8.4 million to be paid out to the plaintiffs.

Under the terms of this particular settlement, Mead Johnson will make permanent changes to how it labels Enfamil products that were named in the lawsuit.

Does Enfamil cause NEC?

There seems to be a correlation between premature babies who developed NEC and the Enfamil infant formula, and this could be for various reasons.

Premature infants have an increased risk of contracting NEC since their gut, and digestive tract is still immature in comparison to non-premature babies.

Some Enfamil formulas contain maltodextrin, a carbohydrate derived from starches that are commonly used as a thickener or filler in various food products.

This, along with other ingredients, can be difficult for premature infants to digest and may contribute to the development of NEC.

Mead Johnson, the company that manufactures Enfamil, denies that its products are to blame for any babies developing NEC.

They claim that there is no scientific evidence to support the assertion that their products are dangerous and that even babies fed breast milk can contract NEC.

Is Enfamil toxic?

While Enfamil itself may not be toxic, it can pose threats to premature infants in particular.

Some research suggests that formula milk leads to necrotizing enterocolitis because of the composition of infant formula, how fast the baby drinks it, or the underdeveloped state of the intestines’ mucous membranes.

Although it’s true that babies fed breast milk can still develop this condition, studies show that the rate is much lower among breastfed babies.

Who is Similac?

Similac is a popular brand of infant formula products owned by Abbott Laboratories, one of the largest pharmaceutical companies in the world.

The Similac brand offers a variety of formulas for different feeding needs, including products for premature babies who can’t have their mother’s breast milk or who have special dietary requirements such as allergies or intolerances.

In recent years, the Similac brand has been embroiled in controversy after several lawsuits were filed alleging that its cow’s milk formulas were the direct cause of NEC health problems in infants.

What is NEC?

Necrotizing enterocolitis, or NEC, is a serious and potentially life-threatening condition that occurs when the tissue in the intestine becomes inflamed and starts to die.

This can lead to a hole in the intestine, sepsis (a potentially fatal infection of the blood), and even death.

It’s believed that premature infants who intake cow milk formulas are more likely to develop NEC than those who feed on human breast milk since their intestines are not fully developed and are more susceptible to inflammation.

NEC is most common in premature babies, but it can also occur in full-term infants.

The condition is typically diagnosed when a baby starts showing signs of distress, such as vomiting, bloating, bloody stools, and decreased appetite.

If your baby is exhibiting any of these symptoms, it’s important to take them to the doctor right away for a diagnosis.

There is no definitive cause of NEC, but there are several risk factors have been identified.

These include being born prematurely, having a low birth weight, being fed cow milk-based formulas, and having a weakened immune system.

While there is no sure way to prevent NEC, there are steps that can be taken, including feeding the baby breast milk if possible, avoiding certain trigger foods, and keeping their immune system strong.

What are the latest developments in the Toxic Baby Formula NEC Lawsuit?

As of October 2022, the schedule and protocol for selecting bellwether cases in the NEC class action lawsuit are well underway.

Bellwether cases are chosen to get a feel for how juries might react to certain evidence and which issues they find important.

The plaintiffs and defendants have given the judge a list of 66 cases that are still pending, from which the court could choose one at random to become the first NEC lawsuit to go to trial.

The trial will progress to the next stage, pretrial discovery, with 12 cases that have been selected as bellwethers.

The pretrial discovery phase involves both sides gathering information and evidence from the other party through means such as depositions, document production, and interrogatories.

This process can be lengthy, so it is still unclear when the first NEC trial will actually take place.

Then, four cases will be chosen for preliminary bellwether test trials.

The plaintiffs and defendants will each choose four cases from the group of 12, and then the court will randomly select the final four cases.

All this will likely be completed by November 23, 2022.

The initial bellwether test trials will include four out of the twelve cases from the discovery phase.

The plaintiffs and defendants each get to choose two cases for the trial.

There will be a total of four bellwether trials taking place every twelve weeks, switching off between plaintiff and defendant-selected cases.

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Written By:
Picture of Jessie Paluch
Jessie Paluch

Experienced Attorney & Legal SaaS CEO

With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!

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Here, at Tru Lawsuit Info, we’re committed to helping victims get the justice they deserve.

To do this, we actively work to connect them with attorneys who are experts in litigating cases similar to theirs.

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